Allergic Rhinitis
Conditions
Interventions
Treatment Group:Endoscopic Temperature-Controlled Ablation of the Posterior Nasal Nerve Combined with the Anterior Ethmoid Nerve
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 70 years (inclusive), regardless of gender; 2. Diagnosed with perennial moderate-to-severe allergic rhinitis (according to guideline classification); 3. History of standardized pharmacological treatment: Received standardized treatment including intranasal corticosteroids (e.g., fluticasone propionate or mometasone furoate nasal spray, 1–2 sprays daily) for >=12 weeks, with inadequate symptom control. At the screening visit, the 24-hour reflective Total Nasal Symptom Score (rTNSS) must be >=6 (maximum score 12); 4. Allergen testing: Serum-specific IgE positive (>=0.35 kU/L) or skin prick test (SPT) positive (++ or higher); 5. Voluntary participation in the study, with full understanding and provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1. Coagulation disorders or ongoing use of anticoagulant medications (e.g., aspirin, warfarin, etc.) that cannot be discontinued as required during the perioperative period; 2. Active tuberculosis, uncontrolled fungal or viral infection; uncontrolled episodic asthma, or poor physical condition that precludes tolerance of the procedure; 3. Participation in any other drug or device clinical trial within the past 3 months; 4. Recent acute upper respiratory infection or severe infectious disease; 5. Severe nasal septum deviation or structural nasal abnormalities that restrict instrument access; 6. Acute inflammation of the nasal cavity or active infection of the nasal cavity/sinuses; 7. Malignancy or other autoimmune diseases; 8. History of significant dry eye, rhinitis medicamentosa, or head/neck radiation therapy; 9. Severe mental or psychological disorders (e.g., major depressive disorder), alcohol dependence, or history of substance abuse; 10. History of multiple drug allergies, allergy or intolerance to anesthetic agents; 11. Pregnancy or lactation; 12. Patients with implanted cardiac pacemakers or other metal implants; 13. Any other condition deemed by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in rTNSS at 24 weeks postoperatively;Proportion of subjects with >=30% improvement in rTNSS from baseline at 24 weeks postoperatively (response rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in rTNSS score at 2, 4, 12, 24, and 48 weeks postoperatively;Change from baseline in total and domain scores of the Rhinosinusitis Quality of Life Questionnaire (RQLQ) at 2, 4, 12, 24, and 48 weeks postoperatively;Symptom improvement response rate at 12 weeks postoperatively (total effective rate = excellent response rate + good response rate);Pain VAS score during early postoperative period;Patient overall treatment satisfaction score at 2, 4, 12, 24, and 48 weeks postoperatively;Change from baseline in endoscopic Lund-Kennedy score at 2, 4, 12, 24, and 48 weeks postoperatively;Change from baseline in medication score at 2, 4, 12, 24, and 48 weeks postoperatively;Number of acute rhinitis episodes within 24 weeks postoperatively;Laboratory assessments (peripheral blood eosinophil count, Treg, Breg, IgE); | — |
Countries
China
Contacts
Public ContactZhou Shuang
Shanghai Tenth People's Hospital
Outcome results
None listed